FDA Device recall Z-2425-2020
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1
- FDA Device
- Class II
- ongoing
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 by Zest Anchors, citing the abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2425-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-22 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zest Anchors |
| Distribution | US |
Product
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Reason
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
Identifiers
| code_info | The UDI number for the affected lots are as follows: Product Name Part # LOCATOR Overdenture Implant, 2.4mmD x 12m…The UDI number for the affected lots are as follows: Product Name Part # LOCATOR Overdenture Implant, 2.4mmD x 12mmL,2.5mm Cuff 07451 Lot # L17MB; UDI Number: 00840481101496 LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff 07456 Lot # Ll5PB; L166F; UDI Number: 00840481101526 LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 4mm Cuff 07465 Lot # L15H7; L15H9; UDI Number: 00840481101571 LOCATOR Overdenture Implant, 2.9mmD x 14mmL, 4mm Cuff 07467 Lot # USHA UDI Number: 00840481101595 LOCATOR Overdenture Implant, 3.4mmD x 12mmL, 4mm Cuff 07476 Lot # L17VE; UDI Number: 00840481126116 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2425-2020%22
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